Pharmacogenetic Analysis to Reduce Events.MORENCT00653653
Medication Optimisation for Reducing Events in a Private Practice Setting
An observational study of Pharmacogenetic Analysis to Reduce Events., run by Awenydd GmbH at 1 site in Germany.
Trial summary
Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that patients having their medication altered to fit their genetic status and/or having their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacogenetic Analysis to Reduce Events.
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample.
Who may be able to join
- older than 18 years
- not demented
- 1 or more documented events in the previous 6 months.
- more than one medication
- multi-morbid
Who cannot join
- demented
- life expectancy less than 1 year
- heart attack within the last 6 months
- Marcumar® Therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.
Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that patients having their medication altered to fit their genetic status and/or having their medication altered because of inherent interaction potential will have less recordable events after genotyping and medical analysis than before.
It is well known that ADRs (recordable adverse events to medication) are responsible for a large number of deaths and hospitalizations. Furthermore it is well recorded that genotyping of individual cytochrome P450 enzymes (2D6, 2C9, 2C19, among others) is directly related to a metabolic phenotype - fast metabolisers, slow metabolisers, intermediate and normal metabolisers. These differing phenotypes have altered metabolism of many medications and in a number of retrospective clinical trails it has been shown that ADRs and effect can be reduced/bettered through genotyping and alteration of medication.
- Keywords
- pharmacogenetics, pharmacoeconomics, adverse events, drug metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Recruited patients will be prospectively observed as one cohort with genotyping/medication interaction analysis after 3 months, followed up by a further 3 month observational period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of reported events in the time frame.
Measured: 3 months
Secondary outcomes (1)
Reduction of total costs associated per patient in the time frame.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacogenetic Analysis to Reduce Events.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Awenydd GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lee S Griffith, Ph.D., Study director, Awenydd GmbHAndré Gessner, MD Ph.D., Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653653
- Sponsor's protocol ID
- AW_SH_08
- Acronym
- MORE
- Status last verified
- Apr 2009
- First submitted
- 2 Apr 2008
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chialda L, Griffith LS, Heinig A, Pahl A. Prospective use of CYP pharmacogenetics and medication analysis to facilitate improved therapy - a pilot study. Per Med. 2008 Jan;5(1):37-45. doi: 10.2217/17410541.5.1.37.
PubMed 29783392
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.
- ClinicalTrials.gov ID
- NCT00653653
- Acronym / sponsor ID
- MORE / AW_SH_08
- Keywords
- pharmacogenetics, pharmacoeconomics, adverse events, drug metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Awenydd GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that patients having their medication altered to fit their genetic status and/or having their medication altered because of inherent interaction potential will have less recordable events after genotyping and medical analysis than before.
It is well known that ADRs (recordable adverse events to medication) are responsible for a large number of deaths and hospitalizations. Furthermore it is well recorded that genotyping of individual cytochrome P450 enzymes (2D6, 2C9, 2C19, among others) is directly related to a metabolic phenotype - fast metabolisers, slow metabolisers, intermediate and normal metabolisers. These differing phenotypes have altered metabolism of many medications and in a number of retrospective clinical trails it has been shown that ADRs and effect can be reduced/bettered through genotyping and alteration of medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Recruited patients will be prospectively observed as one cohort with genotyping/medication interaction analysis after 3 months, followed up by a further 3 month observational period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample.
Key inclusion criteria (5 listed)
- older than 18 years
- not demented
- 1 or more documented events in the previous 6 months.
- more than one medication
- multi-morbid
Key exclusion criteria (4 listed)
- demented
- life expectancy less than 1 year
- heart attack within the last 6 months
- Marcumar® Therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction of reported events in the time frame.
Time frame: 3 months
1 secondary outcome
Reduction of total costs associated per patient in the time frame.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
- Background: PubMed 29783392Chialda L, Griffith LS, Heinig A, Pahl A. Prospective use of CYP pharmacogenetics and medication analysis to facilitate improved therapy - a pilot study. Per Med. 2008 Jan;5(1):37-45. doi: 10.2217/17410541.5.1.37.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee S Griffith, Ph.D. study director
Awenydd GmbH
André Gessner, MD Ph.D. principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacogenetic Analysis to Reduce Events., run by Awenydd GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of reported events in the time frame. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00653653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2009.